Regulations

43 Results

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

High quality services in CDMO: Indena’s leadership in a strategic market

Indena | 16-Mar-2020 | Technical / White Paper

Contract manufacturers are required to heavily invest in building new facilities. Thanks to its strategic choices of investment moves and the adoption...

Make the move to PyroMAT™ System: the only cell line-based Monocyte Activation Test for the detection of pyrogens

Merck KGaA, Darmstadt, Germany | Recorded the 25-Oct-2018 | Webinar

For pharmaceutical companies, patient safety has always been the priority. That’s why pyrogen detection has become a mandatory Quality Control test for...

Enabling drug traceability. Implementing serialization in practice as a CDMO.

R-Pharm Germany GmbH | Recorded the 10-Oct-2017 | Webinar

R-Pharm Germany has established an effective track & trace system to meet all regulatory requirements and to offer cost-effective and customer-oriented...

Cleanroom and Isolator Instrumentation: Best Practices

Merck KGaA, Darmstadt, Germany | Recorded the 08-Dec-2016 | Webinar

Choosing and implementing your environmental monitoring instruments is critical for a safe production & continued compliance. Ensure optimum performance...

FDA Focus̶ Product Design and Post Approval Changes

Colorcon Inc. | 19-Sep-2016 | Technical / White Paper

Review a new Colorcon Technical Paper offering a summary of key points presented in the recent US Center for Drug Evaluation and Research (CDER) Guidance...

Amino Acid Analysis of Pharmaceutical Products

SGS Life Science Services | 11-Jul-2016 | Technical / White Paper

Amino Acid Analysis in general can be used for identification testing of biopharmaceutical active ingredients and the determination of impurities and related...

Rapid Microbiological Method Statistics & Validation

EMD Millipore | Recorded the 17-May-2016 | Webinar

It is well known that implementation of Rapid Microbiological Methods in Pharma environments is accompanied by a large validation workload to ensure that...

Free On-Demand Webinar: Overcoming Your Rapid Microbial Method Validation Challenges.

EMD Millipore | Recorded the 03-Dec-2015 | Webinar

Merck Millipore, Life Science subsidiary of Merck, Darmstadt, Germany, invites you to join a free, on-demand webinar on ways to overcome rapid microbial...